Sunrise® a New Medical Device to Diagnose Sleep Apnea Syndrome

Sleep Apnea Syndrome, Obstructive Clinical Trial

— SENSAPNEA  

Official title:

Evaluation of the Correlation Between the Respiratory Index Events Generated by Sunrise® Versus Polysomnography for Sleep Apnea Syndrome Diagnosis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04262557
• Other study ID #: 38RC19.358
• Status: Completed
• Phase: N/A
• Start date: May 18, 2020
• Est. completion date: September 28, 2020

Study information

• Verified date: October 2020
• Source: University Hospital, Grenoble
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Sleep Apnea Syndrome (SAS) is a serious health issue that should be managed in order to limit its adverse health consequences. SAS is known to induce cardiovascular diseases, diabetes and depression. The prevalence of SAS is still growing with social and economic repercussion. Today, polysomnography (PSG) is the gold standard reference method for SAS diagnosis. However, it is a constraining and expensive technology. In order to improve patients' life quality, many new technologies have been developed for the SAS diagnosis.

The aim of this study is to evaluate the Sunrise®, a new medical integrated solution for SAS diagnosis, in comparison with PSG. This solution consists in a chin sensor recording mandibular movements and measuring the respiratory event index (ERI) through an artificial intelligence algorithm analysis.

Description:

Sunrise® is a type IIa medical device with the CE label. It is a new home sleep technology, non-invasive, reliable and affordable by the patient.

The objective of this study is to evaluate the efficiency of the device in comparison with PSG for sleep apnea diagnosis.

40 subjects, suspected to be apneic, will be equipped at home by the chin sensor, the Sunrise® device, recording their mandibular movements while sleeping. The Sunrise® solution will provide the respiratory event index (REI) as well as the respiratory micro-arousals.

Inclusion visit will be executed at the University Hospital Grenoble Alpes. However, PSG and Sunrise® will be set at the patient's home by IC@dom. The first night, the patient will be equipped by both PSG and Sunrise® and only by the Sunrise® for the two following nights.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: September 28, 2020
• Est. primary completion date: September 28, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Patients suspected to have a sleep apnea syndrome (Berlin score=2)

• Able to use a smartphone application

• Be legally able to give consent

• Person affiliated to social security

Exclusion Criteria:

• Patients already treated for SAS

• Patients suffering from a chronic obstructive or restrictive pulmonary disease with or without oxygen.

• Patients suffering from a unstable cardiovascular disease or a severe heart failure requiring an hospitalzation in the previous three months or conform with the New York Heart Association criteria for class II or III diseases

• Patients treated with myorelaxant medicines

• Patients with a long beard disabling the setting of the mandibular sensor

• Subjects listed in articles L1121-5 à L1121-8: Pregnant women, feeding and parturient; subject under administrative or judicial control, persons who are protected under the act.

• Person in exclusion period for another study or participating in a medical study testing drugs.

• Subjects not being cooperative or respecting the study instructions, according the investigator.

Related Conditions & MeSH terms

• Apnea
• Sleep Apnea Syndrome, Obstructive
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive
• Syndrome

Intervention

Diagnostic Test:
• Sunrise® solution
Type II medical device with the CE label. It is a chin sensor associated to an integrated and connected platform.
• Polysomnography
Gold standard method to diagnose SAS used as comparator

Locations

Country	Name	City	State
France	University Hospital Grenoble Alpes	Grenoble

Sponsors (4)

Lead Sponsor	Collaborator
University Hospital, Grenoble	DOCAPOST, Icadom, SUNRISE

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The performance of Sunrise® to detect the respiratory event index (REI)	Evaluation of the correlation between Sunrise® and PSG for the estimation of the REI	1 night
Secondary	Evaluation of the Sunrise® reproductibility on three consecutive nights	REI measured by Sunrise® on three consecutive nights	3 nights
Secondary	Evaluation of the sleep quality: depth of sleep	Depth of sleep was assessed by the St Mary Hospital Questionnaire Q1 (scale from 1 "very light" to 8 "very depth"), after one night without device, one night with PSG+Sunrise® and one night with Sunrise® only	3 nights
Secondary	Evaluation of the sleep quality: number of wake-ups	Number of Wake-ups was assessed by the St Mary Hospital Questionnaire Q2 (scale from 0 "no Wake-up" to 7 "more than 6 Wake-ups"), after one night without device, one night with PSG+Sunrise® and one night with Sunrise® only	3 nights
Secondary	Evaluation of the sleep quality: sleep duration	Sleep duration was assessed by the St Mary Hospital Questionnaire Q3 (in hour), after one night without device, one night with PSG+Sunrise® and one night with Sunrise® only	3 nights